Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode

K231405 is the FDA 510(k) clearance record for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode, a class II device, cleared for Jiangsu Rong FU Kang Medical Instruments Co., Ltd. on 2024-01-18 under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list one 510(k) clearance for Jiangsu Rong FU Kang Medical Instruments Co., Ltd. As of 2026-09-10, FDA records show no recalls naming K231405.